Class III · Low risk
Testosterone Topical Solution
Defective Container: Repetitive complaints received indicating pump not working.
FDA Drug Recalls
152 recalls · Class III, newest first
Class III · Low risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Subpotent Drug.
Class III · Low risk
Mirapex (pramipexole dihydrochloride)
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Class III · Low risk
ATHLETICARE Anti-Bacterial Hand Soap AC 550
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Class III · Low risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 9-monthstability timepoint
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Class III · Low risk
Oxybutynin Chloride
Failed Dissolution Specifications
Class III · Low risk
Lovastatin Tablets USP
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class III · Low risk
Temozolomide Capsules
Failed dissolution specifications
Class III · Low risk
Lovastatin Tablets USP
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class III · Low risk
Ciclopirox shampoo 1%
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Class III · Low risk
Mometasone Furoate Cream
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules USP
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Class III · Low risk
Oxytocin 30 Units added to NS 500 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 20 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 10 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Class III · Low risk
Diltiazem HCl CD capsules
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.